Trial Outcomes & Findings for A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants (NCT NCT00412737)
NCT ID: NCT00412737
Last Updated: 2016-06-10
Results Overview
Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than \[\>\] 37.2 degrees Celsius \[°C\]) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum hemagglutination inhibition (HAI) titers measured from baseline to any point during the study.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
477 participants
Primary outcome timeframe
From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Results posted on
2016-06-10
Participant Flow
Out of total 477 participants who were randomized to receive study treatments, 2 participants were not included in the study population due to lack of efficacy data. Thus, results are reported only for 475 participants.
One participant was randomized to placebo group but received oseltamivir for the first 9 weeks of the study. This participant was included in the placebo group in the Intention-to-treat (ITT) analysis population, but in the oseltamivir group in the safety analysis population.
Participant milestones
| Measure |
Placebo
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
|
Oseltamivir
Oseltamivir 30 milligram (mg) to 75 mg capsule or suspension orally once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
237
|
238
|
|
Overall Study
COMPLETED
|
221
|
232
|
|
Overall Study
NOT COMPLETED
|
16
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
|
Oseltamivir
Oseltamivir 30 milligram (mg) to 75 mg capsule or suspension orally once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Refused Treatment
|
6
|
2
|
|
Overall Study
Failure to Return
|
6
|
2
|
Baseline Characteristics
A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants
Baseline characteristics by cohort
| Measure |
Placebo
n=237 Participants
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
|
Oseltamivir
n=238 Participants
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
|
Total
n=475 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.9 years
STANDARD_DEVIATION 15.67 • n=5 Participants
|
49.4 years
STANDARD_DEVIATION 15.47 • n=7 Participants
|
49.2 years
STANDARD_DEVIATION 15.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
151 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
315 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)Population: ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. Participants were analyzed as per initial randomization.
Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than \[\>\] 37.2 degrees Celsius \[°C\]) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum hemagglutination inhibition (HAI) titers measured from baseline to any point during the study.
Outcome measures
| Measure |
Placebo
n=238 Participants
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
|
Oseltamivir
n=237 Participants
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population
|
7 participants
|
5 participants
|
SECONDARY outcome
Timeframe: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)Population: Per-Protocol (PP) population was defined as the subset of the ITT population who did not have any major protocol violations which would impact the assessment of efficacy.
Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.
Outcome measures
| Measure |
Placebo
n=208 Participants
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
|
Oseltamivir
n=220 Participants
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population
|
6 participants
|
4 participants
|
SECONDARY outcome
Timeframe: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)Population: ITTNAB population was defined as the subset of the ITT population who were culture negative at baseline.
Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.
Outcome measures
| Measure |
Placebo
n=231 Participants
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
|
Oseltamivir
n=232 Participants
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population
|
7 participants
|
4 participants
|
SECONDARY outcome
Timeframe: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)Population: ITT population.
RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.
Outcome measures
| Measure |
Placebo
n=238 Participants
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
|
Oseltamivir
n=237 Participants
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population
|
7 participants
|
2 participants
|
SECONDARY outcome
Timeframe: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)Population: ITTNAB population.
RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.
Outcome measures
| Measure |
Placebo
n=231 Participants
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
|
Oseltamivir
n=232 Participants
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population
|
7 participants
|
1 participants
|
SECONDARY outcome
Timeframe: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)Population: ITT population.
RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.
Outcome measures
| Measure |
Placebo
n=238 Participants
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
|
Oseltamivir
n=237 Participants
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population
|
8 participants
|
5 participants
|
SECONDARY outcome
Timeframe: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)Population: ITTNAB population.
RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.
Outcome measures
| Measure |
Placebo
n=231 Participants
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
|
Oseltamivir
n=232 Participants
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITTNAB Population
|
8 participants
|
4 participants
|
Adverse Events
Placebo
Serious events: 23 serious events
Other events: 40 other events
Deaths: 0 deaths
Oseltamivir
Serious events: 18 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=237 participants at risk
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
|
Oseltamivir
n=238 participants at risk
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
|
|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
1.7%
4/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Infections and infestations
Pneumonia
|
1.3%
3/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.42%
1/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Infections and infestations
Pyelonephritis acute
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.42%
1/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.42%
1/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Infections and infestations
Bronchitis
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Infections and infestations
Gastroenteritis viral
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Infections and infestations
Influenza
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Infections and infestations
Urinary tract infection
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Cardiac disorders
Angina pectoris
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.42%
1/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Cardiac disorders
Pericardial effusion
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.42%
1/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.42%
1/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.42%
1/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Nervous system disorders
Syncope
|
0.00%
0/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.42%
1/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.00%
0/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.42%
1/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.84%
2/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Renal and urinary disorders
Nephropathy
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
General disorders
Drug interaction
|
0.00%
0/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.42%
1/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
General disorders
Pyrexia
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Hepatobiliary disorders
Cholangitis
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.42%
1/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Immune system disorders
Acute graft versus host disease
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Immune system disorders
Transplant rejection
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.42%
1/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Investigations
Weight decreased
|
0.00%
0/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.42%
1/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Psychiatric disorders
Depression
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.42%
1/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.00%
0/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
0.42%
1/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
Other adverse events
| Measure |
Placebo
n=237 participants at risk
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
|
Oseltamivir
n=238 participants at risk
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.6%
18/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
6.3%
15/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Nervous system disorders
Headache
|
5.1%
12/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
4.6%
11/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
9/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
5.5%
13/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
|
General disorders
Fatigue
|
3.0%
7/237 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
5.0%
12/238 • From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
Safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER