NCT01592370 · OUTCOME
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid
An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma · Source last updated 2025-10-22
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month
Analysis population: All Treated Participants
Groups in this outcome
Nivolumab Monotherapy (Expansion)
3mg/kg of nivolumab
Nivolumab + Ipilimumab
3 mg/kg of nivolumab and
1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
Nivolumab + Lirilumab
3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Nivolumab Monotherapy (Expansion) | 83 |
|---|
| Nivolumab + Ipilimumab | 47 |
|---|
| Nivolumab + Lirilumab | 72 |
|---|
Reported measurements
TSH > ULN
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab Monotherapy (Expansion) | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Ipilimumab | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Lirilumab | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
TSH > ULN WITH TSH <= ULN AT BASELINE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab Monotherapy (Expansion) | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Ipilimumab | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Lirilumab | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab Monotherapy (Expansion) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Ipilimumab | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Lirilumab | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab Monotherapy (Expansion) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Ipilimumab | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Lirilumab | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
TSH > ULN WITH FT3/FT4 TEST MISSING
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab Monotherapy (Expansion) | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Ipilimumab | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Lirilumab | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
TSH < LLN
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab Monotherapy (Expansion) | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Ipilimumab | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Lirilumab | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
TSH < LLN WITH TSH >= LLN AT BASELINE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab Monotherapy (Expansion) | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Ipilimumab | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Lirilumab | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab Monotherapy (Expansion) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Ipilimumab | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Lirilumab | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab Monotherapy (Expansion) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Ipilimumab | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Lirilumab | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
TSH < LLN WITH FT3/FT4 TEST MISSING
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab Monotherapy (Expansion) | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Ipilimumab | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Lirilumab | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 15
- title
- TSH > ULN
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 9
- title
- TSH > ULN WITH TSH <= ULN AT BASELINE
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 1
- title
- TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- title
- TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 13
- title
- TSH > ULN WITH FT3/FT4 TEST MISSING
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- title
- TSH < LLN
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 4
- title
- TSH < LLN WITH TSH >= LLN AT BASELINE
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- title
- TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 5
- title
- TSH < LLN WITH FT3/FT4 TEST MISSING
- denoms
- counts
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 47
- group Id
- OG002
- value
- 72
- units
- Participants
- groups
- description
- 3mg/kg of nivolumab
- id
- OG000
- title
- Nivolumab Monotherapy (Expansion)
- description
- 3 mg/kg of nivolumab and
1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
- id
- OG001
- title
- Nivolumab + Ipilimumab
- description
- 3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
- id
- OG002
- title
- Nivolumab + Lirilumab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All Treated Participants
- reporting Status
- POSTED
- time Frame
- Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month
- title
- Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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