[ { "nct": "NCT00318461", "time_frame": "Adverse events were collected over 24 months of treatment", "description": "The safety analysis set is all randomised subjects who were exposed to at least one dose of study product." }, { "nct": "NCT00375492", "time_frame": "", "description": "" }, { "nct": "NCT00395746", "time_frame": "Adverse events were collected in a time span over 52 weeks.", "description": "The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS)." }, { "nct": "NCT00500370", "time_frame": "", "description": "" }, { "nct": "NCT00516074", "time_frame": "", "description": "" }, { "nct": "NCT00518115", "time_frame": "On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.", "description": "SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment." }, { "nct": "NCT00577824", "time_frame": "Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).", "description": "" }, { "nct": "NCT00603239", "time_frame": "Adverse events were collected from baseline to endpoint, regardless of relationship to study drug. Events were captured as actual terms and coded to MedDRA,version 12.0.", "description": "" }, { "nct": "NCT00620282", "time_frame": "The adverse events were collected from week 0 to week 12.", "description": "The full safety analysis set is all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure." }, { "nct": "NCT00630825", "time_frame": "", "description": "" }, { "nct": "NCT00658021", "time_frame": "Serious AEs: From first dose of study drug (Day 1) up to 30 days after last dose of study drug, approximately 32 weeks. Non-serious AEs: From first dose of study drug (Day 1) up to 1 day after last dose of study drug, approximately 28 weeks.", "description": "The Safety Analysis Set included all participants who received at least 1 dose of randomized study medication.\n\nTreatment-emergent AEs (TEAEs) are reported. A TEAE was defined as an AE starting (or worsening) after the first dose of randomized study medication through the end of treatment + 1 day for non-serious AEs or + 30 days for serious AEs." }, { "nct": "NCT00688701", "time_frame": "First dose of study drug up to 3 days after the last dose administration", "description": "Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered." }, { "nct": "NCT00696657", "time_frame": "The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.", "description": "The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T." }, { "nct": "NCT00701935", "time_frame": "", "description": "" }, { "nct": "NCT00712673", "time_frame": "First dose of study drug up to 3 days after the last dose administration", "description": "Median exposure to study treatment were 564, 561.5 and 567.5 days for the morning lixisenatide, evening lixisenatide combined placebo treatment arms, respectively.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered." }, { "nct": "NCT00713830", "time_frame": "First dose of study drug up to 3 days after the last dose administration, for up to 120 weeks", "description": "Median exposure to study treatment was 617 and 610 days in placebo and lixisenatide treatment arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered. The one patient in the placebo group who received Lixisenatide was analyzed in the Lixisenatide group" }, { "nct": "NCT00715624", "time_frame": "First dose of study drug up to 3 days after the last dose administration for up to 125 weeks", "description": "Median exposure to study treatment was 560 and 559 days in lixisenatide and placebo treatment arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered." }, { "nct": "NCT00763451", "time_frame": "First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks", "description": "Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered." }, { "nct": "NCT00763815", "time_frame": "First dose of study drug up to 3 days after the last dose administration, for up to 132 weeks", "description": "Median exposure to study treatment was 615.5 and 588.0 days in lixisenatide and placebo treatment arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered." }, { "nct": "NCT00765817", "time_frame": "", "description": "" }, { "nct": "NCT00781937", "time_frame": "Treatment emergent adverse events were defined as occurring before randomisation and increasing in severity during treatment, or had onset on or after first day of randomised treatment and no later than 7 days after last day of randomised treatment.", "description": "Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product." }, { "nct": "NCT00782418", "time_frame": "Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed.", "description": "AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Subjects were queried at each visit for any adverse experiences since the previous visit." }, { "nct": "NCT00791479", "time_frame": "", "description": "" }, { "nct": "NCT00838903", "time_frame": "On-treatment serious adverse events (SAEs) and non-serious AEs, defined as those events that had a start date on or after the first day of study medication and within 56 days after the end of study medication (up to Week 156), are reported.", "description": "SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment." }, { "nct": "NCT00839527", "time_frame": "On-treatment serious adverse events (SAEs) and non-serious AEs, defined as those events that had a start date on or after the first day of study medication and within 56 days after the end of study medication (up to Week 156), are reported.", "description": "SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment." }, { "nct": "NCT00845507", "time_frame": "Up to 16 weeks", "description": "" }, { "nct": "NCT00849017", "time_frame": "On-treatment serious adverse events (SAEs) and non-serious AEs, defined as those events that had a start date on or after the first day of study medication and within 56 days after the end of study medication (up to Week 156), are reported.", "description": "SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment." }, { "nct": "NCT00849056", "time_frame": "On-treatment serious adverse events (SAEs) and non-serious AEs, defined as those events that had a start date on or after the first day of study medication and within 56 days after the end of study medication (up to Week 156), are reported.", "description": "SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment." }, { "nct": "NCT00856609", "time_frame": "", "description": "" }, { "nct": "NCT00866658", "time_frame": "First dose of study drug up to 3 days after the last dose administration", "description": "Median exposure to study treatment was 169 days in both arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered." }, { "nct": "NCT00882050", "time_frame": "AEs were collected on each subject from time of signed consent until 24 hours post surgery. This time frame was approximately one month.", "description": "Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research." }, { "nct": "NCT00894322", "time_frame": "Day 1 to Week 12", "description": "" }, { "nct": "NCT00975286", "time_frame": "First dose of study drug up to 3 days after the last dose administration", "description": "Median exposure to study treatment was 169 days in both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered." }, { "nct": "NCT01001104", "time_frame": "", "description": "" }, { "nct": "NCT01064687", "time_frame": "", "description": "" }, { "nct": "NCT01098461", "time_frame": "On-therapy serious adverse events (SAEs)/non-serious AEs, with a start date on/after the first day of study medication (SM) and within 56 days after the end of SM, were collected from the start of SM until Follow-up/Early Withdrawal (up to Study Day 168).", "description": "On-therapy SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all enrolled participants who received at least one dose of study treatment. Participants were analyzed according to treatment received." }, { "nct": "NCT01136798", "time_frame": "6 weeks", "description": "" }, { "nct": "NCT01144338", "time_frame": "During study period up to 7.5 years", "description": "Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed." }, { "nct": "NCT01147250", "time_frame": "All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame.", "description": "Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP." }, { "nct": "NCT01149421", "time_frame": "", "description": "" }, { "nct": "NCT01154933", "time_frame": "", "description": "participants were monitored/assessed for possible adverse events, but none occurred" }, { "nct": "NCT01169779", "time_frame": "First dose of study drug up to 3 days after the last dose administration", "description": "Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered." }, { "nct": "NCT01179048", "time_frame": "Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).", "description": "Safety was assessed using the full analysis set which included all randomised subjects.\n\nSerious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events." }, { "nct": "NCT01206101", "time_frame": "Adverse events were collected from week 0 to week 52.", "description": "Safety analysis set includes all subjects who received at least one dose of the trial product or its comparator." }, { "nct": "NCT01234649", "time_frame": "Data collected over 5 years of trial", "description": "" }, { "nct": "NCT01255163", "time_frame": "Up to 18 months", "description": "Description of AEs according to clinicaltrials.gov definitions" }, { "nct": "NCT01272219", "time_frame": "For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).", "description": "A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the \"pre-diabetic arms\" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the \"no pre-diabetes arms\" (Arm 1 and Arm 2)" }, { "nct": "NCT01272232", "time_frame": "Adverse events were recorded for up to 68 weeks.", "description": "Safety Analysis Set comprising all randomised subjects who had been exposed to at least one dose of trial product." }, { "nct": "NCT01324388", "time_frame": "", "description": "" }, { "nct": "NCT01364584", "time_frame": "", "description": "" }, { "nct": "NCT01392573", "time_frame": "Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).", "description": "Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation \"as treated\"." }, { "nct": "NCT01394952", "time_frame": "From Randomization to Study Completion (Up to 7 Years)", "description": "All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly." }, { "nct": "NCT01473953", "time_frame": "The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)", "description": "The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'." }, { "nct": "NCT01475734", "time_frame": "SAEs and non-serious AEs were collected from the time the participant consented to participate in the study through the end of the study, or the final follow-up visit for participants who discontinued active participation in the study (up to 8 weeks).", "description": "On-therapy SAEs and non-serious AEs (onset on or after the first day of study medication) were collected in members of the Safety Population, comprised of all randomly assigned study participants who received at least one dose of study medication." }, { "nct": "NCT01505673", "time_frame": "6 months", "description": "" }, { "nct": "NCT01554618", "time_frame": "After the first dose of study medication in period through the end of the treatment in period + 90 days for SAEs (or + 7 days for non-serious (i.e. Other) AEs. Overall time frame: up to maximum of approximately 37 weeks and 41 weeks for controlled assessment period and extension period, respectively.", "description": "The Safety Analysis Set consisted of all patients who received at least 1 dose of study medication. One patient who was randomized to placebo received a dose of exenatide in error and was subsequently reassigned to the exenatide treatment group for analyses based on actual treatment (ie, for analyses based on the Safety Analysis Set)." }, { "nct": "NCT01557166", "time_frame": "Events that either occur before randomisation and increase in severity during the treatment period or have an onset date on or after the first day of randomised treatment and no later than 14 days after the last day of randomised treatment.", "description": "Safety analysis set - included all randomised subjects exposed to trial drug." }, { "nct": "NCT01572740", "time_frame": "Adverse events were collected in a timeframe of 36 weeks + 7 days follow up.", "description": "Safety analysis set includes all subjects who received at least one dose of the trial products." }, { "nct": "NCT01617434", "time_frame": "Week 0 to Week 26 + 7 days follow up", "description": "Safety analysis set includes all subjects who received at least one dose of the trial product." }, { "nct": "NCT01620489", "time_frame": "The adverse events were collected from Week 0 to Week 27±3 Days", "description": "Safety analysis set included all subjects receiving at least one dose of the investigational product." }, { "nct": "NCT01667900", "time_frame": "", "description": "" }, { "nct": "NCT01720446", "time_frame": "Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).", "description": "Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised." }, { "nct": "NCT01722240", "time_frame": "56 weeks", "description": "Safety data is collected for 56 weeks (4 weeks before randomization and 52 after randomization)" }, { "nct": "NCT01722266", "time_frame": "12 weeks.", "description": "" }, { "nct": "NCT01753362", "time_frame": "26 weeks", "description": "" }, { "nct": "NCT01769378", "time_frame": "", "description": "" }, { "nct": "NCT01784965", "time_frame": "", "description": "" }, { "nct": "NCT01798706", "time_frame": "All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (Day 171) regardless of seriousness or relationship to investigational medicinal product (IMP).", "description": "Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose of study drug up to 3 days after the last dose of study drug)." }, { "nct": "NCT01800968", "time_frame": "Baseline to day 210.", "description": "All serious adverse events documented from baseline to day 210. According to protocol: Non-serious adverse events will not be collected on the eCRF but should be documented in source documents and followed according to local standard of care. Non-serious adverse events were not reported to sponsor, and therefore not reported." }, { "nct": "NCT01836523", "time_frame": "Up to 52 weeks", "description": "A treatment emergent adverse event is defined as an event with onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment." }, { "nct": "NCT01923181", "time_frame": "Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.", "description": "Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product." }, { "nct": "NCT01928329", "time_frame": "Up to 12 months.", "description": "Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm." }, { "nct": "NCT02020616", "time_frame": "", "description": "One participant was discontinued from the study before dosing due to meeting exclusion criteria." }, { "nct": "NCT02054897", "time_frame": "From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)", "description": "Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo." }, { "nct": "NCT02073929", "time_frame": "", "description": "" }, { "nct": "NCT02098395", "time_frame": "From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26).", "description": "Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo." }, { "nct": "NCT02152371", "time_frame": "", "description": "" }, { "nct": "NCT02160990", "time_frame": "30 days", "description": "" }, { "nct": "NCT02229383", "time_frame": "From Baseline (Day 1) up to Week 28", "description": "Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period." }, { "nct": "NCT02229396", "time_frame": "From baseline (Day 1) up to Week 104 (28-week Treatment Period + 24-week Extension Period 1 + 52-week Extension Period 2).", "description": "Treatment-emergent adverse event data is reported for the Safety Analysis set defined as all randomized patients receiving at least 1 dose of study medication. One patient who was randomized did not receive study medication (the patient was randomized in error); this patient was not counted as completing or discontinuing treatment." }, { "nct": "NCT02251431", "time_frame": "38 weeks from study initiation", "description": "" }, { "nct": "NCT02284009", "time_frame": "On-therapy AEs and SAEs were collected from start of study treatment up to 52-weeks", "description": "AEs and SAEs were summarized in Safety Population. Safety Population comprised of all participants who received at least one dose of study treatment." }, { "nct": "NCT02288273", "time_frame": "18 weeks", "description": "" }, { "nct": "NCT02299388", "time_frame": "", "description": "" }, { "nct": "NCT02305381", "time_frame": "From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks).", "description": "A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period." }, { "nct": "NCT02417142", "time_frame": "24 weeks", "description": "" }, { "nct": "NCT02443155", "time_frame": "Weeks 0-80", "description": "All reported adverse events are treatment-emergent. Results are based on the safety analysis set (SAS) which included all participants who received at least one dose of randomised treatment." }, { "nct": "NCT02453711", "time_frame": "Week 0 up to Week 59 (treatment period: week 0 to week 52 + follow-up period: week 53 to week 59).", "description": "All AEs mentioned here are treatment-emergent adverse events (TEAEs), which was defined as any AE reported after first trial product administration and until last trial product administration with a 7-week follow-up period. Results are based on the safety analysis set, which included all subjects receiving at least 1 dose of randomised treatment." }, { "nct": "NCT02461589", "time_frame": "From baseline up to week 33.", "description": "Safety analysis set (SAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation \"as treated\". Treatment-emergent adverse events (TEAEs) were defined as events recorded from the first dose of trial product and until completion of the post-treatment follow-up visit (7 weeks)." }, { "nct": "NCT02465515", "time_frame": "On-therapy non-SAEs and SAEs were reported on or after treatment start date and within 56 days after treatment stop date (Up to 2.7 years)", "description": "SAEs, non-SAELDs and non-SAEs of pre-specified interest were reported systematically in the Safety Population. Some investigators collected other non-SAEs for some participants (i.e. non-systematically). CV events referred for adjudication as study endpoints were not duplicate reported as AEs. Deaths were reported for ITT Population." }, { "nct": "NCT02496611", "time_frame": "Adverse event and serious adverse event data was collected from Baseline to Week 52.", "description": "The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA." }, { "nct": "NCT02548585", "time_frame": "From Day 1 to follow-up period (28 days after the last study dose for each cohort [approximately 60 days])", "description": "" }, { "nct": "NCT02597049", "time_frame": "Baseline to end of study (up to 24 weeks)", "description": "All participants who received at least one dose of study drug." }, { "nct": "NCT02647944", "time_frame": "16 weeks", "description": "" }, { "nct": "NCT02664441", "time_frame": "Double-Blind Randomized Phase - From Study Visit 1 (0 weeks) through end of Study Visit 4 (36 weeks); Open Label Extension - From Study Visit 4 (36 Weeks) through end of Study Visit 5 (54 weeks)", "description": "" }, { "nct": "NCT02692716", "time_frame": "Week 0 to 87. SAEs and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.", "description": "Systematic collection of AEs was limited to SAEs, AEs leading to permanent discontinuation of trial product, medication errors leading to SAEs, severe hypoglycaemic episodes, hepatic events, pregnancies and AEs related to technical complaints and were summarised. Non-serious AEs not fulfilling the above criteria were not systematically collected." }, { "nct": "NCT02750410", "time_frame": "Up to 52 weeks", "description": "All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period." }, { "nct": "NCT02759107", "time_frame": "Baseline to end of study (Up to 57 days)", "description": "All randomized participants who received at least 1 dose of the study drug." }, { "nct": "NCT02765399", "time_frame": "During 16 weeks of Liraglutide therapy", "description": "" }, { "nct": "NCT02777073", "time_frame": "throughout patient participation period of 8hr and up to 72 hrs follow-up after the dose administration", "description": "No adverse events occurred during the study." }, { "nct": "NCT02827708", "time_frame": "Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.", "description": "Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product." }, { "nct": "NCT02863419", "time_frame": "Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.", "description": "Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product." }, { "nct": "NCT02906930", "time_frame": "Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.", "description": "Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product." }, { "nct": "NCT02918279", "time_frame": "Week 0-56 + 14 days. Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product.", "description": "All presented adverse events are TEAEs. A TEAE was defined as an event that occurred in the \"on-treatment\" period. 'On-treatment' period: Events with onset date between the first day of trial product administration and any of the following date, whichever came first: 1) 14 days after the last day on trial product, or 2) follow-up visit (week 58) for participants who discontinued trial product, or 3) last study visit (participants withdrawn without follow-up visit)." }, { "nct": "NCT02953665", "time_frame": "Adverse Event collection commenced upon signing of consent at Screening and occurred at Baseline Week 1, Week 2, Week 6, Week 14, Week 28, Week 38, Week 54, and at follow-up Week 58.", "description": "" }, { "nct": "NCT02962492", "time_frame": "12 weeks", "description": "Patients were mainly monitored for 2 adverse events (also considered serious adverse events) throughout the study (12 weeks) related to:\n\n1. severe hypoglycemia (blood sugar \\<35mg/dl and requiring assistance)\n2. diagnosis of diabetic ketoacidosis" }, { "nct": "NCT02963766", "time_frame": "Up To 56 Weeks", "description": "All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly." }, { "nct": "NCT02963922", "time_frame": "From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days.", "description": "Evaluation of safety was based on SAS which comprised of all randomised participants who received at least one dose of trial product.\n\nAEs with onset during the on-treatment observation period (the period when participants were exposed to trial product) were considered treatment-emergent." }, { "nct": "NCT02963935", "time_frame": "From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days.", "description": "Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product.\n\nAEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent." }, { "nct": "NCT02964247", "time_frame": "Week 0 (randomisation visit) to week 26 (end-of-treatment visit) + 7 days", "description": "Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. Safety analysis set includes all subjects exposed to at least one dose of trial product." }, { "nct": "NCT02970942", "time_frame": "From week 0 to week 79 Results are based on the safety analysis set which included all participants who received at least one dose of randomised treatment.", "description": "All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half lives of semaglutide); 2) end of the in-trial period." }, { "nct": "NCT02973100", "time_frame": "Up to 22 weeks", "description": "All participants who received at least one dose of study drug." }, { "nct": "NCT02973321", "time_frame": "All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).", "description": "Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8)." }, { "nct": "NCT02975297", "time_frame": "10 weeks", "description": "" }, { "nct": "NCT02981069", "time_frame": "Baseline to 6 months", "description": "Patient reporting and physical exam by principal investigator/nurse coordinator" }, { "nct": "NCT03018028", "time_frame": "Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.", "description": "Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product." }, { "nct": "NCT03021187", "time_frame": "Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.", "description": "Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product." }, { "nct": "NCT03029351", "time_frame": "52 weeks", "description": "" }, { "nct": "NCT03038620", "time_frame": "For the entire duration of the study: 40 weeks.", "description": "Adverse events collected at each study visit. GI side effects captured and reported in summary form." }, { "nct": "NCT03041792", "time_frame": "From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.", "description": "The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study." }, { "nct": "NCT03048578", "time_frame": "1 year", "description": "" }, { "nct": "NCT03086330", "time_frame": "Week 0 to week 30 (treatment period) + 42 days (follow-up period). All the reported adverse events (AEs) are TEAEs.", "description": "Results are based on the SAS. Treatment with semaglutide or placebo followed a fixed dose escalation. The maintenance dose of semaglutide 1.0 mg was reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg. The same fixed dose escalation scheme was followed for placebo, with respective dose matching volume. Hence, the adverse events are combinedly presented under 2 respective reporting groups, 'semaglutide 1.0 mg and placebo'." }, { "nct": "NCT03115424", "time_frame": "Adverse Events were collected from baseline to end of study, approximately 36 months", "description": "" }, { "nct": "NCT03131687", "time_frame": "Up To 34 Weeks", "description": "All randomized participants who received at least one dose of study drug." }, { "nct": "NCT03158805", "time_frame": "Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up", "description": "" }, { "nct": "NCT03235050", "time_frame": "Adverse events were collected from time of first IP dose throughout the 54-week treatment period and including the 28-day follow-up period. Serious AEs were recorded from the time of signature of informed consent.", "description": "" }, { "nct": "NCT03244800", "time_frame": "From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)", "description": "" }, { "nct": "NCT03279731", "time_frame": "from the beginning to the end of the 17 week trial", "description": "Adverse event data collection occurred at each study visit." }, { "nct": "NCT03311724", "time_frame": "Baseline through end of study (Up to 15 weeks).", "description": "All randomized participants." }, { "nct": "NCT03322631", "time_frame": "Up To 85 days", "description": "All randomized participants who received at least one dose of study drug" }, { "nct": "NCT03353350", "time_frame": "All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.", "description": "" }, { "nct": "NCT03444584", "time_frame": "Day 1 through 28 days after the last dose of MEDI0382 (approximately 8 weeks)", "description": "" }, { "nct": "NCT03480022", "time_frame": "36 weeks", "description": "" }, { "nct": "NCT03486392", "time_frame": "Up to 30 Weeks", "description": "Safety analysis set included all randomized participants who had received at least one dose of study drug." }, { "nct": "NCT03496298", "time_frame": "From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months).", "description": "Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received." }, { "nct": "NCT03523273", "time_frame": "Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.", "description": "" }, { "nct": "NCT03548935", "time_frame": "week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of Semaglutide or placebo.", "description": "All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomized treatment and no later than the date of last dose + 7 weeks." }, { "nct": "NCT03548987", "time_frame": "week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.", "description": "All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks." }, { "nct": "NCT03550378", "time_frame": "Day 1 through Day 60", "description": "" }, { "nct": "NCT03552757", "time_frame": "Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment.", "description": "All presented AEs are treatment-emergent (i.e., TEAEs)." }, { "nct": "NCT03555994", "time_frame": "Post dosing (Day 1) to final follow-up (28 Days post last dose)", "description": "" }, { "nct": "NCT03574597", "time_frame": "From randomisation (week 0) up to 240 weeks", "description": "AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo)." }, { "nct": "NCT03596177", "time_frame": "Day 17 through 28 days post last dose (approximately 14 months)", "description": "From Day 1 to Day 16 all participants in both treatment arms received placebo so that analysis of energy intake in participants who were randomised to MEDI0382 may be performed. Hence, TEAEs were not applicable for Day 1 to Day 16. The TEAEs were recorded and reported for double-blind treatment period ie, from Day 17." }, { "nct": "NCT03611582", "time_frame": "week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.", "description": "All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks." }, { "nct": "NCT03645421", "time_frame": "Treatment-emergent AEs were collected from Day 1 of treatment up to 14 days after the last dose of IP (approximately 9 weeks).", "description": "AEs are presented for the Safety Analysis Set which included all randomised patients who received at least 1 dose of IP, analysed according to the treatment received." }, { "nct": "NCT03693430", "time_frame": "From Baseline (Week 0) to Week 111", "description": "All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomized treatment and no later than the date of last dose + 7 weeks. Results are based on the SAS which included all randomized participants exposed to at least one dose of randomized treatment." }, { "nct": "NCT03712098", "time_frame": "8 months", "description": "The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description." }, { "nct": "NCT03713684", "time_frame": "All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60).", "description": "TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \\[i.e. up to Week 60\\]). Analysis was performed on safety population." }, { "nct": "NCT03743025", "time_frame": "Information on adverse events was collected among participants who had elective CABG surgery, beginning at the time of consent and continued through the final assessment occurring 30 days after discharge from the hospital, up to 42 days postoperatively.", "description": "Information was collected for the following specific adverse events:sternal wound infection, bacteremia, pneumonia, acute kidney injury, acute myocardial infarction, nausea, vomiting, ileus, and pancreatitis." }, { "nct": "NCT03745937", "time_frame": "Baseline (Day -1) through 28 days post last dose (approximately up to 5 months)", "description": "" }, { "nct": "NCT03770728", "time_frame": "All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of investigational medicinal product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 34).", "description": "TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population." }, { "nct": "NCT03811574", "time_frame": "Week 0 to week 75.", "description": "All presented AEs are treatment-emergent (i.e., TEAEs). Adverse events were defined as \"treatment-emergent\" (TEAE), if the onset of the event occurs in the on-treatment period. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment." }, { "nct": "NCT03819153", "time_frame": "From Week 0 up to Week 238", "description": "The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol." }, { "nct": "NCT03856047", "time_frame": "From week 0 to week 32 Results are based on the safety analysis set which included all randomised participants exposed to at least one dose of randomised treatment.", "description": "All presented adverse events are treatment emergent adverse events (TEAEs). TEAE is defined as an event that had onset date during the on-treatment period. On-treatment period was from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide." }, { "nct": "NCT03914326", "time_frame": "From Week 0 up to Week 265", "description": "The safety evaluation data as reported by the investigator was based on the Full Analysis Set." }, { "nct": "NCT03951753", "time_frame": "Up to Week 32", "description": "All randomly assigned participants who received at least 1 dose of study drug and have evaluable data." }, { "nct": "NCT03954834", "time_frame": "Baseline to end of Safety follow-up (up to 44 weeks)", "description": "All randomized participants who received at least one dose of study drug." }, { "nct": "NCT03985293", "time_frame": "Baseline up to Week 21", "description": "Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event." }, { "nct": "NCT03987451", "time_frame": "From week 0 to week 55. Results are based on the safety analysis set which included all participants who received at least one dose of randomised treatment.", "description": "All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during on-treatment period. On-treatment period which started on the date of first administration of trial product and ended on the date of whatever comes first of: a) last dose of trial product + 49 days (7 half-lives of semaglutide), b) follow-up visit (week 55), or c) end of the in-trial period (week 55)." }, { "nct": "NCT04019197", "time_frame": "Adverse event data were collected for participants during the time when each participant was receiving active drug or placebo (32 weeks). Participants were evaluated weekly for possible side-effects of the study drug and adverse events.", "description": "All collected laboratory values listed in the National Institute of Allergy and Infectious Diseases, Division of AIDS adverse events table (corrected version 2.1, 2017) were recorded and graded based on severity. All listed clinical conditions in the table plus additional symptoms with known associations to semaglutide (eg, cholelithiasis) or those that could indicate a possible drug side-effect (eg, shakiness from hypoglycemia) were also recorded and graded similarly." }, { "nct": "NCT04019561", "time_frame": "Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks.", "description": "One participant randomized to 600ug received 300ug." }, { "nct": "NCT04039503", "time_frame": "Baseline, 17 Months", "description": "All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly." }, { "nct": "NCT04074161", "time_frame": "From week 0 to week 75", "description": "All presented AEs are treatment-emergent (i.e., TEAEs). TEAEs defined as AEs, with the onset of the event occurred in the on-treatment period. Results are based on the SAS which included all randomized participants exposed to at least one dose of randomized treatment." }, { "nct": "NCT04081337", "time_frame": "Baseline Through End of Safety Follow-up (Up to 22 Weeks)", "description": "All randomized participants who received at least one dose of study drug, regardless of whether they completed all protocol requirements. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups." }, { "nct": "NCT04102189", "time_frame": "From baseline (week 0) to week 75", "description": "All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>7 consecutive missed doses (corresponding to \\>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment." }, { "nct": "NCT04109547", "time_frame": "From week 0 to week 31", "description": "All presented adverse events (AEs) are treatment-emergent (i.e., TEAEs). TEAE was defined as an AE with onset in the on-treatment observation period.\n\nResults are based on the safety analysis set (SAS) which included all participants exposed to at least one dose of trial product." }, { "nct": "NCT04126603", "time_frame": "24 weeks", "description": "Patients monitored by laboratory results every 2 months and questions of general well-being" }, { "nct": "NCT04153929", "time_frame": "From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days.", "description": "Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug." }, { "nct": "NCT04166773", "time_frame": "Baseline Up to Week 56", "description": "All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly" }, { "nct": "NCT04184622", "time_frame": "Baseline up to Week 193", "description": "* All randomized participants who received at least 1 dose of the study drug.\n* As per the pre-specified statistical analysis plan, safety data were analyzed and reported by randomized arms regardless of the actual treatment received by the participant.\n* Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly." }, { "nct": "NCT04199728", "time_frame": "54 days", "description": "Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events." }, { "nct": "NCT04235959", "time_frame": "Up To 43 Weeks", "description": "All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received." }, { "nct": "NCT04251156", "time_frame": "Week 0 to week 51", "description": "All presented AEs are TEAEs, defined as an event with onset during the on-treatment observation period. Results are based on the SAS which included all randomized participants exposed to at least one dose of randomized treatment." }, { "nct": "NCT04311411", "time_frame": "Baseline up to 10 Weeks", "description": "All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received." }, { "nct": "NCT04515576", "time_frame": "Baseline through final follow-up at Day 57", "description": "All participants who received at least one dose of study drug." }, { "nct": "NCT04515849", "time_frame": "Screening throughout the treatment period and including the follow-up period (28 days post last dose), an average of 37 weeks.", "description": "" }, { "nct": "NCT04552470", "time_frame": "Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks)", "description": "Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention." }, { "nct": "NCT04560998", "time_frame": "Until week 57", "description": "All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period." }, { "nct": "NCT04591626", "time_frame": "Baseline Through End of Safety Follow-Up (Up To 32 Weeks)", "description": "All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly." }, { "nct": "NCT04596631", "time_frame": "From Baseline (Week 0) up to 57 weeks", "description": "Adverse event (AE) is an unfavourable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of time after the study has ended. TEAE is defined as an AE with onset in the on-treatment observation period. SAS included all randomized participants who received at least one dose of trial product." }, { "nct": "NCT04617275", "time_frame": "Baseline through follow-up (Day 112-119).", "description": "Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event." }, { "nct": "NCT04624672", "time_frame": "6 months", "description": "" }, { "nct": "NCT04657003", "time_frame": "Baseline through Week 76", "description": "All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly." }, { "nct": "NCT04657016", "time_frame": "Baseline up to week 76", "description": "All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level." }, { "nct": "NCT04660643", "time_frame": "Week 0 to 36 for the open-label lead-in period arm, Week 36 to 92 for the double-blind study period arms.", "description": "All participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of dose." }, { "nct": "NCT04667377", "time_frame": "From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.", "description": "Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation).\n\nTreated Set (TS): All randomised participants who received at least one dose of study treatment." }, { "nct": "NCT04707313", "time_frame": "From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)", "description": "An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \\>=5% of participants in any treatment group are included below." }, { "nct": "NCT04741074", "time_frame": "9 months", "description": "Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events." }, { "nct": "NCT04771273", "time_frame": "[All-Cause Mortality], [Serious Adverse Events], [Other Adverse Events]: From first study drug administration until last study drug administration plus 28 days of residual effect period (REP), up to 365 days.", "description": "Treated set - actual maintenance treatment: included all patients that were administered survodutide or placebo matching survodutide. Patients are analyzed according to the actual treatment they received at the start of the dose maintenance phase (for patients who reached the maintenance period) or the next maintenance dose up from the dose at treatment discontinuation (for patients who discontinued treatment prior to the maintenance period)." }, { "nct": "NCT04779697", "time_frame": "12 weeks", "description": "" }, { "nct": "NCT04788511", "time_frame": "From baseline (week 0) to end of trial (week 57)", "description": "All presented adverse events are treatment-emergent adverse events (TEAEs). A TEAEs was defined as an event that had onset during the on-treatment period (date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least five consecutive missed doses). SAS included all the participants who randomly assigned to trial treatment and who took at least one dose of trial product." }, { "nct": "NCT04844918", "time_frame": "Baseline Through Safety Follow-Up (Up To 76 Weeks)", "description": "All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level." }, { "nct": "NCT04847557", "time_frame": "Baseline Up To 162 Weeks", "description": "All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received." }, { "nct": "NCT04862234", "time_frame": "Information on adverse events was collected from the time that individuals gave consent to participate in the study through the final assessment at hospital discharge, up to 5 days postoperatively.", "description": "" }, { "nct": "NCT04865770", "time_frame": "Up to week 57", "description": "Safety analysis set- all participants randomly assigned to trial treatment \\& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm." }, { "nct": "NCT04867785", "time_frame": "Baseline Through Study Completion (Up to 280 Days)", "description": "All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly." }, { "nct": "NCT04881760", "time_frame": "Baseline Through End of Safety Follow-up (Up to 52 Weeks)", "description": "All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups." }, { "nct": "NCT04889157", "time_frame": "Baseline up to 35 days after last dose (Day 91)", "description": "" }, { "nct": "NCT04971785", "time_frame": "All-cause mortality and Adverse events: Up to 72 weeks plus 35 days", "description": "All-cause mortality: The All Randomized Analysis Set included all participants who were randomized in the study.\n\nAdverse events: The Safety Analysis Set included all participants who received at least 1 dose of study drug." }, { "nct": "NCT04982575", "time_frame": "From baseline (week 0) to week 37", "description": "AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \\& ends at first date of any of following; date of last dose of trial product +35 days for AEs \\& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product." }, { "nct": "NCT04998136", "time_frame": "From (week 0) to (week 49).", "description": "All presented AEs are TEAEs (treatment emergent adverse events).\n\nAdverse events will be defined as \"treatment-emergent\" (TEAE), if the onset of the event occurs in the on-treatment period.\n\nSafety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received." }, { "nct": "NCT05024032", "time_frame": "Baseline Through Safety Follow-Up (Up To Week 56)", "description": "All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per protocol, adverse event analysis was planned as per the treatment regimen received." }, { "nct": "NCT05035095", "time_frame": "From baseline (week 0) to end-of-study (week 75)", "description": "All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received." }, { "nct": "NCT05040971", "time_frame": "From randomisation (week 0) to week 57", "description": "All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product." }, { "nct": "NCT05048719", "time_frame": "Baseline Through Safety Follow-Up (Up To Week 28)", "description": "All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly." }, { "nct": "NCT05051579", "time_frame": "Baseline through Week 38 (36 weeks with 2 weeks safety follow up)", "description": "All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly." }, { "nct": "NCT05064735", "time_frame": "From baseline (week 0) to end of trial (week 75)", "description": "All presented adverse events are treatment-emergent adverse events (TEAEs). A TEAEs was defined as an event that had onset during the on-treatment period (date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least two consecutive missed doses). SAS included all randomized participants exposed to at least one dose of randomized treatment." }, { "nct": "NCT05086445", "time_frame": "Baseline Through Follow-Up (Up To Week 15)", "description": "All participants from Part A and Part B who received at least one dose of study drug. For Part B, as specified in the statistical analysis plan, analyses were performed for the pre-specified treatment groups: placebo, 2(or 3)/3/6/12 mg LY3502970, 2/3/6/8/12/24 mg LY3502970, and 2(or 3)/6/12/24/36/45 mg LY3502970." }, { "nct": "NCT05132088", "time_frame": "Week 0 to week 75", "description": "Presented AEs are TEAEs, defined as an event with onset during on-treatment observation period. On-treatment is date of first trial product administration (week 0) to date of last trial product administration (week 68) excluding potential off-treatment time intervals of more than 3 consecutive days. For evaluation of AEs the lag time for each on-treatment time interval is 7 weeks. Results are based on SAS which included all randomised participants exposed to at least one dose of trial product." }, { "nct": "NCT05144984", "time_frame": "From baseline (week 0) to week 39", "description": "All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment." }, { "nct": "NCT05260021", "time_frame": "Baseline Up to Week 56", "description": "All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts.\n\nPer analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods." }, { "nct": "NCT05347147", "time_frame": "Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.", "description": "Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the \"All subjects pre-treatment group\". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \\[active or placebo\\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the \"Placebo\" and \"Presendin\" groups." }, { "nct": "NCT05364931", "time_frame": "From first dose on Day 1 up to approximately 52 weeks.", "description": "" }, { "nct": "NCT05412004", "time_frame": "Baseline to Follow-up (Up To 56 Weeks)", "description": "All randomized participants who are exposed to at least 1 dose of study intervention. As per the prespecified statistical analysis plan, adverse events were analyzed as per the treatment regimen. Gender-specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly." }, { "nct": "NCT05486065", "time_frame": "From baseline (week 0) up to end of study (week 49)", "description": "AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment." }, { "nct": "NCT05520775", "time_frame": "From the Baseline medical visit through follow-up, a total of up to 12 weeks.", "description": "" }, { "nct": "NCT05530577", "time_frame": "From the Baseline medical visit through follow-up, a total of up to 12 weeks.", "description": "" }, { "nct": "NCT05537233", "time_frame": "from signing consent from till end of the study (i.e 26 weeks)", "description": "" }, { "nct": "NCT05548647", "time_frame": "From enrollment until end of treatment, up to 72 weeks", "description": "" }, { "nct": "NCT05564117", "time_frame": "From week 0 to week 71", "description": "All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study." }, { "nct": "NCT05646706", "time_frame": "From baseline (week 0) to end of study (week 81)", "description": "Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study." }, { "nct": "NCT05649137", "time_frame": "From week 0 to week 81", "description": "Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period." }, { "nct": "NCT05691712", "time_frame": "Baseline up to week 44", "description": "All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly." }, { "nct": "NCT05696847", "time_frame": "Baseline Up To 14 Weeks", "description": "All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received." }, { "nct": "NCT05869903", "time_frame": "Baseline Up to Week 74", "description": "* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen.\n* Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly." }, { "nct": "NCT05872620", "time_frame": "Baseline Up to Week 74", "description": "* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen.\n* Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly." }, { "nct": "NCT05891496", "time_frame": "From baseline (week 0) to end of study (week 69)", "description": "All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention." }, { "nct": "NCT05931380", "time_frame": "Baseline up to end of follow-up (up to 74 weeks)", "description": "All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses." }, { "nct": "NCT05963022", "time_frame": "Baseline up to week 44", "description": "All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly." }, { "nct": "NCT05971940", "time_frame": "Baseline to end of safety follow-up (up to 42 weeks)", "description": "* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses.\n* Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly." }, { "nct": "NCT06023095", "time_frame": "Baseline up to 182 Days", "description": "All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received." }, { "nct": "NCT06041217", "time_frame": "From baseline (week 0) to end of study (week 49)", "description": "An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP." }, { "nct": "NCT06109311", "time_frame": "Baseline to end of safety follow-up (up to 42 weeks)", "description": "* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of doses.\n* Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly." }, { "nct": "NCT06124807", "time_frame": "Baseline up to Week 56", "description": "All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly." } ]