TriangleNCT00123474 · OUTCOME
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led toTreatment Discontinuation After 7 Year Follow-up
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline to 30 days post last dose, up to 7 years (study closure July 2014)
What was measured
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Baseline=closest to, but no later than, the first day of study drug for treated participants. After the 2-year analysis and Protocol Amendment 02, those on a BID dosing schedule were allowed to switch to a QD dosing schedule. Due to the large number of participants switching from BID dosing to QD dosing, the abbreviated dosing data collection method incorporated in Amendment 03, the overall safety data are presented for the 100 mg QD group and combined for the other treatment groups.
Analysis population: All randomized participants who received at least one dose of study drug were summarized.
Groups in this outcome
100 mg QD
Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
Other Treatment Groups
Participants participated in all other treatment arms until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
Total
Participants received study drug in any schedule or total daily dose until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
| Group | Source count |
|---|---|
| 100 mg QD | 165 |
| Other Treatment Groups | 497 |
| Total | 662 |
Reported measurements
All Deaths
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100 mg QD | 51 | Not reported | Not reported | Not reported | Not reported |
| Other Treatment Groups | 133 | Not reported | Not reported | Not reported | Not reported |
| Total | 184 | Not reported | Not reported | Not reported | Not reported |
Deaths on-study or within 30 days post dose
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100 mg QD | 11 | Not reported | Not reported | Not reported | Not reported |
| Other Treatment Groups | 15 | Not reported | Not reported | Not reported | Not reported |
| Total | 26 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100 mg QD | 75 | Not reported | Not reported | Not reported | Not reported |
| Other Treatment Groups | 259 | Not reported | Not reported | Not reported | Not reported |
| Total | 334 | Not reported | Not reported | Not reported | Not reported |
AEs Leading to Discontinuation of Treatment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100 mg QD | 43 | Not reported | Not reported | Not reported | Not reported |
| Other Treatment Groups | 153 | Not reported | Not reported | Not reported | Not reported |
| Total | 196 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 51
- group Id
- OG001
- value
- 133
- group Id
- OG002
- value
- 184
- title
- All Deaths
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 26
- title
- Deaths on-study or within 30 days post dose
- categories
- measurements
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 259
- group Id
- OG002
- value
- 334
- title
- SAEs
- categories
- measurements
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 153
- group Id
- OG002
- value
- 196
- title
- AEs Leading to Discontinuation of Treatment
- denoms
- counts
- group Id
- OG000
- value
- 165
- group Id
- OG001
- value
- 497
- group Id
- OG002
- value
- 662
- units
- Participants
- description
- AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Baseline=closest to, but no later than, the first day of study drug for treated participants. After the 2-year analysis and Protocol Amendment 02, those on a BID dosing schedule were allowed to switch to a QD dosing schedule. Due to the large number of participants switching from BID dosing to QD dosing, the abbreviated dosing data collection method incorporated in Amendment 03, the overall safety data are presented for the 100 mg QD group and combined for the other treatment groups.
- groups
- description
- Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
- id
- OG000
- title
- 100 mg QD
- description
- Participants participated in all other treatment arms until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
- id
- OG001
- title
- Other Treatment Groups
- description
- Participants received study drug in any schedule or total daily dose until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
- id
- OG002
- title
- Total
- param Type
- NUMBER
- population Description
- All randomized participants who received at least one dose of study drug were summarized.
- reporting Status
- POSTED
- time Frame
- Baseline to 30 days post last dose, up to 7 years (study closure July 2014)
- title
- Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led toTreatment Discontinuation After 7 Year Follow-up
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice