Trial Outcomes & Findings for Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma (NCT NCT01180049)
NCT ID: NCT01180049
Last Updated: 2019-05-20
Results Overview
PFS is defined as the time from randomization to first documentation of disease progression by the independent assessor or to death due to any cause, whichever occurred first. PFS = (earliest date of progression or death due to any cause- randomization date+1)/30.4. PFS assessment was done using EMA guidelines for sensitivity analysis censoring. Participants who were alive and progression-free at the time of analysis were censored on the date of last assessment; participants without adequate baseline assessment or without post-baseline assessments were censored on the randomization date; participants who died or progressed after 2 or more missed visits were censored on the date of last tumor assessment prior to the missing visit; and participants who started new anti-cancer therapy prior to death or progression were censored on the date of last tumor assessment prior to the start of anti-tumor treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
101 participants
Primary outcome timeframe
From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)
Results posted on
2019-05-20
Participant Flow
The study was conducted at multiple centers from 10 Mar 2011 to 28 Jun 2018.
Participant milestones
| Measure |
TEMSR 175/75 mg
Participants had received desipramine 50 milligrams (mg) one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
|
TEMSR 75 mg
Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
48
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
53
|
48
|
Reasons for withdrawal
| Measure |
TEMSR 175/75 mg
Participants had received desipramine 50 milligrams (mg) one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
|
TEMSR 75 mg
Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
|
|---|---|---|
|
Overall Study
Other
|
9
|
7
|
|
Overall Study
Lost to Follow-up
|
8
|
6
|
|
Overall Study
Death
|
36
|
35
|
Baseline Characteristics
Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
TEMSR 175/75 mg
n=53 Participants
Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
|
TEMSR 75 mg
n=48 Participants
Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.2 Years
STANDARD_DEVIATION 9.11 • n=99 Participants
|
66.3 Years
STANDARD_DEVIATION 8.36 • n=107 Participants
|
66.8 Years
STANDARD_DEVIATION 8.73 • n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)Population: The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.
PFS is defined as the time from randomization to first documentation of disease progression by the independent assessor or to death due to any cause, whichever occurred first. PFS = (earliest date of progression or death due to any cause- randomization date+1)/30.4. PFS assessment was done using EMA guidelines for sensitivity analysis censoring. Participants who were alive and progression-free at the time of analysis were censored on the date of last assessment; participants without adequate baseline assessment or without post-baseline assessments were censored on the randomization date; participants who died or progressed after 2 or more missed visits were censored on the date of last tumor assessment prior to the missing visit; and participants who started new anti-cancer therapy prior to death or progression were censored on the date of last tumor assessment prior to the start of anti-tumor treatment.
Outcome measures
| Measure |
TEMSR 175/75 mg
n=47 Participants
Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
|
TEMSR 75 mg
n=43 Participants
Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
|
|---|---|---|
|
Independently Assessed Progression-free Survival (PFS)
|
4.3 Months
Interval 3.3 to 6.4
|
4.5 Months
Interval 2.7 to 4.9
|
SECONDARY outcome
Timeframe: From randomization date until death due to any cause (average follow up done for 56.1 months)Population: Analysis was done on ITT population. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
OS is defined as the time from the date of randomization to the date of death due to any cause.
Outcome measures
| Measure |
TEMSR 175/75 mg
n=53 Participants
Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
|
TEMSR 75 mg
n=48 Participants
Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
|
|---|---|---|
|
Overall Survival (OS)
|
10.9 Months
Interval 7.0 to 19.7
|
11.2 Months
Interval 6.6 to 18.1
|
SECONDARY outcome
Timeframe: From randomization date until end of treatment (average follow up done for 15 months)Population: The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.
ORR is defined as the percentage of participants with confirmed CR or PR according to the Cheson Criteria relative to all randomized Participants. Tumor responses were determined using information from objective measurements from computed tomography information including B-symptom evaluation, physical examination, ECOG performance status, assessment of liver and spleen, laboratory assessments such as bone marrow biopsies and/or aspirates, biochemical markers of disease activity and hematology results. Participants who did not have on-study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the (CT) scans, as well as clinical assessment of ORR.
Outcome measures
| Measure |
TEMSR 175/75 mg
n=47 Participants
Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
|
TEMSR 75 mg
n=43 Participants
Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
|
|---|---|---|
|
Independent Assessment - Objective Response Rate (ORR = CR + PR)
|
27.7 Percentage of participants
Interval 19.1 to 37.7
|
20.9 Percentage of participants
Interval 13.0 to 31.0
|
SECONDARY outcome
Timeframe: From randomization date until end of treatment (average follow up done for 15 months)Population: The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.
ORR is defined as the percentage of participants with confirmed CR or PR according to the Cheson Criteria relative to all randomized Participants. Tumor responses were determined using information from objective measurements from computed tomography information including B-symptom evaluation, physical examination, ECOG performance status, assessment of liver and spleen, laboratory assessments such as bone marrow biopsies and/or aspirates, biochemical markers of disease activity and hematology results. Participants who did not have on-study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the (CT) scans, as well as clinical assessment of ORR.
Outcome measures
| Measure |
TEMSR 175/75 mg
n=47 Participants
Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
|
TEMSR 75 mg
n=43 Participants
Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
|
|---|---|---|
|
Investigator's Assessment ORR (ORR = CR + PR)
|
31.9 Percentage of participants
Interval 22.9 to 42.2
|
18.6 Percentage of participants
Interval 11.1 to 28.5
|
SECONDARY outcome
Timeframe: From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)Population: The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.
PFS is defined as the time from randomization to first documentation of disease progression by the independent assessor or to death due to any cause, whichever occurred first. PFS = (earliest date of progression or death due to any cause- randomization date+1)/30.4. PFS assessment was done using EMA guidelines for sensitivity analysis censoring. Participants who were alive and progression-free at the time of analysis were censored on the date of last assessment; participants without adequate baseline assessment or without post-baseline assessments were censored on the randomization date; participants who died or progressed after 2 or more missed visits were censored on the date of last tumor assessment prior to the missing visit; and participants who started new anti-cancer therapy prior to death or progression were censored on the date of last tumor assessment prior to the start of anti-tumor treatment.
Outcome measures
| Measure |
TEMSR 175/75 mg
n=47 Participants
Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
|
TEMSR 75 mg
n=43 Participants
Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
|
|---|---|---|
|
Investigator Assessed PFS
|
4.7 Months
Interval 2.7 to 8.3
|
3.9 Months
Interval 2.8 to 4.7
|
SECONDARY outcome
Timeframe: From screening up to a maximum of 57.1 monthsPopulation: Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR was included in the evaluation for safety.
An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Treatment emergent adverse event=as an event that emerged during treatment period that was absent before treatment, or worsened during treatment period relative to pretreatment state. Treatment-emergent infection-related AEs included events: pneumonia, bronchitis, infection, herpes simplex, oral candidiasis and sepsis. Grading by NCI CTCAE Version 3.0.: Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening; urgent intervention indicated; Grade 5= death.
Outcome measures
| Measure |
TEMSR 175/75 mg
n=53 Participants
Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
|
TEMSR 75 mg
n=47 Participants
Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
|
|---|---|---|
|
Percentage of Participants With Treatment-Emergent Infection- Related Adverse Events (AEs) With Grade 2 or Higher as Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Infection
|
5.7 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Infection- Related Adverse Events (AEs) With Grade 2 or Higher as Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Pneumonia
|
17.0 Percentage of participants
|
21.3 Percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Infection- Related Adverse Events (AEs) With Grade 2 or Higher as Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Bronchitis
|
7.5 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Infection- Related Adverse Events (AEs) With Grade 2 or Higher as Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Herpes simplex
|
3.8 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Infection- Related Adverse Events (AEs) With Grade 2 or Higher as Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Oral candidiasis
|
3.8 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Infection- Related Adverse Events (AEs) With Grade 2 or Higher as Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Cellulitis
|
1.9 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Infection- Related Adverse Events (AEs) With Grade 2 or Higher as Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Sepsis
|
0 Percentage of participants
|
2.1 Percentage of participants
|
SECONDARY outcome
Timeframe: From screening up to a maximum of 57.1 monthsPopulation: Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR was included in the evaluation for safety.
An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Treatment emergent adverse event=as an event that emerged during treatment period that was absent before treatment, or worsened during treatment period relative to pretreatment state. Treatment-emergent bleeding related AEs included events: epistaxis and ecchymosis. AE were assessed according to maximum severity grading based on NCI CTCAE Version 4.03.Grade 1=mild; Grade 2=moderate; within normal limits. Grade 3=severe or medically significant but not immediately life-threatening; Grade 4=life-threatening or disabling; urgent intervention indicated; Grade 5=death.
Outcome measures
| Measure |
TEMSR 175/75 mg
n=53 Participants
Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
|
TEMSR 75 mg
n=47 Participants
Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
|
|---|---|---|
|
Percentage of Participants With Treatment-Emergent Bleeding-Related AEs With Grade 2 or Higher as Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Epistaxis
|
13.2 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Bleeding-Related AEs With Grade 2 or Higher as Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Ecchymosis
|
1.9 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: From one week predose (Day -7, -4hr, -8hr, -48hr) upto 2 weeks post dose (4hr, 8hr, 48hr and Day 8)Population: The analysis was done on ITT Population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.
Potential TEMSR effects were investigated by calculating the ratio of AUCs with and without concomitant TEMSR from the model-estimated effect of TEMSR on apparent clearance (CL/F) values and using individual ratios of observed Cmax values with and without concomitant temsirolimus, for both parent and metabolite. The AUC mean ratio was calculated as 1 / mean shift on apparent clearance from TEMSR, and the 90% CI of the AUC ratios was calculated as 1 / 90% CI of the shift on apparent clearance from TEMSR. AUC: Area under plasma concentration-time curve from time zero to infinity Cmax: Characterization of maximum observed plasma concentration
Outcome measures
| Measure |
TEMSR 175/75 mg
n=47 Participants
Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
|
TEMSR 75 mg
n=43 Participants
Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
|
|---|---|---|
|
Quantify the Potential Effect of TEMSR on AUC and Cmax
AUC
|
1.00 Ratio
Interval 0.965 to 1.11
|
0.980 Ratio
Interval 0.87 to 1.12
|
|
Quantify the Potential Effect of TEMSR on AUC and Cmax
Cmax
|
0.828 Ratio
Interval 0.758 to 0.898
|
0.779 Ratio
Interval 0.7005 to 0.857
|
Adverse Events
TEMSR 175/75 mg
Serious events: 35 serious events
Other events: 51 other events
Deaths: 0 deaths
TEMSR 75 mg
Serious events: 34 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TEMSR 175/75 mg
n=53 participants at risk
Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
|
TEMSR 75 mg
n=47 participants at risk
Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
|
|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
2/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
4.3%
2/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
4.3%
2/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Cardiac disorders
Myocardial infarction
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Gastrointestinal disorders
Gastric disorder
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
General disorders
Death
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
General disorders
Disease progression
|
18.9%
10/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
19.1%
9/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
General disorders
Pyrexia
|
7.5%
4/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Bronchitis
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Device related infection
|
3.8%
2/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Infection
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Influenza
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Listeria sepsis
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Pneumonia
|
13.2%
7/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
19.1%
9/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Pneumonia pseudomonal
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Sepsis
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Sinusitis
|
3.8%
2/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
4.3%
2/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Viral skin infection
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Investigations
Eastern Cooperative Oncology Group performance status worsened
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Investigations
Haemoglobin
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Investigations
Streptococcus test positive
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.5%
4/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
10.6%
5/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Nervous system disorders
Headache
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Psychiatric disorders
Hallucination
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
3.8%
2/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
6.4%
3/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
4.3%
2/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
4.3%
2/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Cardiac disorders
Atrial fibrillation
|
3.8%
2/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Eye disorders
Cataract
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Gastrointestinal disorders
Colitis
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Gastrointestinal disorders
Gastric perforation
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Cellulitis
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Gastroenteritis
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Investigations
Alanine aminotransferase increased
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Investigations
Aspartate aminotransferase increased
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Investigations
Human rhinovirus test positive
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Atypical pneumonia
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
Other adverse events
| Measure |
TEMSR 175/75 mg
n=53 participants at risk
Participants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg IV once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
|
TEMSR 75 mg
n=47 participants at risk
Participants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
26.4%
14/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
27.7%
13/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.4%
5/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
4.3%
2/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Blood and lymphatic system disorders
Neutropenia
|
34.0%
18/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
23.4%
11/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
69.8%
37/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
59.6%
28/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
8.5%
4/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Eye disorders
Dry eye
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
6.4%
3/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
3/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
12.8%
6/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Gastrointestinal disorders
Constipation
|
11.3%
6/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
10.6%
5/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Gastrointestinal disorders
Diarrhoea
|
35.8%
19/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
29.8%
14/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.7%
3/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
6.4%
3/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Gastrointestinal disorders
Nausea
|
11.3%
6/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
19.1%
9/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Gastrointestinal disorders
Stomatitis
|
13.2%
7/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
8.5%
4/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
2/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
6.4%
3/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
General disorders
Asthenia
|
13.2%
7/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
14.9%
7/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
General disorders
Chest discomfort
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
8.5%
4/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
General disorders
Fatigue
|
20.8%
11/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
27.7%
13/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.3%
6/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
17.0%
8/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
General disorders
Oedema peripheral
|
17.0%
9/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
17.0%
8/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
General disorders
Pyrexia
|
24.5%
13/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
23.4%
11/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Bronchitis
|
7.5%
4/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Herpes simplex
|
7.5%
4/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
4.3%
2/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Infection
|
5.7%
3/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
3/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Pneumonia
|
5.7%
3/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
8.5%
4/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Rhinitis
|
7.5%
4/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Skin infection
|
5.7%
3/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Upper respiratory tract infection
|
18.9%
10/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
21.3%
10/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Urinary tract infection
|
5.7%
3/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
6.4%
3/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
6.4%
3/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Investigations
Blood pressure increased
|
5.7%
3/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Investigations
Platelet count decreased
|
11.3%
6/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
4.3%
2/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Investigations
Weight decreased
|
11.3%
6/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
12.8%
6/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
3.8%
2/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
10.6%
5/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.7%
3/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
10.6%
5/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.5%
4/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
10.6%
5/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
11.3%
6/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
10.6%
5/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.8%
2/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
8.5%
4/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.1%
8/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
17.0%
8/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.7%
3/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
6.4%
3/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
3/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
6.4%
3/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Nervous system disorders
Dysgeusia
|
3.8%
2/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
8.5%
4/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Nervous system disorders
Headache
|
9.4%
5/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
6.4%
3/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
6.4%
3/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Psychiatric disorders
Insomnia
|
7.5%
4/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.1%
8/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
19.1%
9/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.9%
10/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
27.7%
13/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.7%
3/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
10.6%
5/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
26.4%
14/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
19.1%
9/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
6.4%
3/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.5%
4/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
4.3%
2/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
9.4%
5/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
10.6%
5/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
8.5%
4/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
10.6%
5/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
7.5%
4/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.7%
3/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
6.4%
3/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.9%
10/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
17.0%
8/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
6.4%
3/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Vascular disorders
Hypertension
|
5.7%
3/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
General disorders
Mucosal inflammation
|
5.7%
3/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
10.6%
5/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.7%
3/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.7%
3/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
2.1%
1/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
1.9%
1/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
8.5%
4/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Infections and infestations
Oral candidiasis
|
5.7%
3/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
4.3%
2/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Investigations
Blood cholesterol increased
|
5.7%
3/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Renal and urinary disorders
Pollakiuria
|
5.7%
3/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
0.00%
0/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.8%
2/53 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
6.4%
3/47 • From screening up to a maximum of 57.1 months
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 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER