Trial Outcomes & Findings for Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer (NCT NCT03348904)
NCT ID: NCT03348904
Last Updated: 2019-06-13
Results Overview
Defined as the time from randomization to the date of death from any cause.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
2 participants
Primary outcome timeframe
Approximately 38 months
Results posted on
2019-06-13
Participant Flow
Approximately 630 participants were planned to be randomized. Prior to the termination of the study, 2 participants were randomized to the Platinum Doublet Chemotherapy arm (Arm B) and treated.
Participant milestones
| Measure |
Nivolumab + Epacadostat/Platinum Doublet Chemotherapy
Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following:
Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.
Optional continuation maintenance was available every 3 weeks, if eligible.
|
Platinum Doublet Chemotherapy
Platinum Doublet Chemotherapy included the following:
Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.
Optional continuation maintenance was available every 3 weeks, if eligible.
|
Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy
Nivolumab plus placebo in combination with platinum doublet chemotherapy included:
Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.
Optional continuation maintenance was available every 3 weeks, if eligible.
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
2
|
0
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Nivolumab + Epacadostat/Platinum Doublet Chemotherapy
Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following:
Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.
Optional continuation maintenance was available every 3 weeks, if eligible.
|
Platinum Doublet Chemotherapy
Platinum Doublet Chemotherapy included the following:
Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.
Optional continuation maintenance was available every 3 weeks, if eligible.
|
Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy
Nivolumab plus placebo in combination with platinum doublet chemotherapy included:
Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.
Optional continuation maintenance was available every 3 weeks, if eligible.
|
|---|---|---|---|
|
Overall Study
Administrative reason by the sponsor
|
0
|
1
|
0
|
Baseline Characteristics
Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Nivolumab + Epacadostat/Platinum Doublet Chemotherapy
Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following:
Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.
Optional continuation maintenance was available every 3 weeks, if eligible.
|
Platinum Doublet Chemotherapy
n=2 Participants
Platinum Doublet Chemotherapy included the following:
Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.
Optional continuation maintenance was available every 3 weeks, if eligible.
|
Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy
Nivolumab plus placebo in combination with platinum doublet chemotherapy included:
Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.
Optional continuation maintenance was available every 3 weeks, if eligible.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Approximately 38 monthsPopulation: All randomized participants; Arm A did not enroll any participants in the study and as a result no comparisons were performed and since the study was terminated early no efficacy analyses were conducted.
Defined as the time from randomization to the date of death from any cause.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Approximately 25 monthsPopulation: All randomized participants; Arm A did not enroll any participants in the study and as a result no comparisons were performed and since the study was terminated early no efficacy analyses were conducted.
Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review, or death due to any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 25 monthsPopulation: All randomized participants; Arm A did not enroll any participants in the study and as a result no comparisons were performed and since the study was terminated early no efficacy analyses were conducted.
Defined as the proportion of participants who achieve a confirmed best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by blinded independent central review.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 25 monthsPopulation: All randomized participants; Arm A did not enroll any participants in the study and as a result no comparisons were performed and since the study was terminated early no efficacy analyses were conducted.
Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 38 monthsPopulation: All randomized participants; Arm C did not enroll any participants in the study and as a result no analyses were performed and since the study was terminated early no efficacy analyses were conducted.
Defined as the time from randomization to the date of death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 25 monthsPopulation: All randomized participants; Arm C did not enroll any participants in the study and as a result no analyses were performed and since the study was terminated early no efficacy analyses were conducted.
Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review or death due to any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 25 monthsPopulation: All randomized participants; Arm C did not enroll any participants in the study and as a result no analyses were performed and since the study was terminated early no efficacy analyses were conducted.
Defined as the proportion of participants who achieve a confirmed best response of CR or PR per RECIST v1.1 criteria as assessed by blinded independent central review.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 25 monthsPopulation: All randomized participants; Arm C did not enroll any participants in the study and as a result no analyses were performed and since the study was terminated early no efficacy analyses were conducted.
Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.
Outcome measures
Outcome data not reported
Adverse Events
Nivolumab + Epacadostat/Platinum Doublet Chemotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Platinum Doublet Chemotherapy
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nivolumab + Epacadostat/Platinum Doublet Chemotherapy
Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following:
Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.
Optional continuation maintenance was available every 3 weeks, if eligible.
|
Platinum Doublet Chemotherapy
n=2 participants at risk
Platinum Doublet Chemotherapy included the following:
Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.
Optional continuation maintenance was available every 3 weeks, if eligible.
|
Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy
Nivolumab plus placebo in combination with platinum doublet chemotherapy included:
Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.
Optional continuation maintenance was available every 3 weeks, if eligible.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
50.0%
1/2 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
50.0%
1/2 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
50.0%
1/2 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
Other adverse events
| Measure |
Nivolumab + Epacadostat/Platinum Doublet Chemotherapy
Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following:
Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.
Optional continuation maintenance was available every 3 weeks, if eligible.
|
Platinum Doublet Chemotherapy
n=2 participants at risk
Platinum Doublet Chemotherapy included the following:
Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.
Optional continuation maintenance was available every 3 weeks, if eligible.
|
Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy
Nivolumab plus placebo in combination with platinum doublet chemotherapy included:
Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.
Optional continuation maintenance was available every 3 weeks, if eligible.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
50.0%
1/2 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
50.0%
1/2 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
50.0%
1/2 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
50.0%
1/2 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
|
Investigations
Weight decreased
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
50.0%
1/2 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
50.0%
1/2 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
|
Vascular disorders
Hypotension
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
50.0%
1/2 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
|
General disorders
Pyrexia
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
50.0%
1/2 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
50.0%
1/2 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
50.0%
1/2 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
|
Psychiatric disorders
Anxiety
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
50.0%
1/2 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
|
Gastrointestinal disorders
Constipation
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
100.0%
2/2 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
50.0%
1/2 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
—
0/0 • From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
All treated participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER