Trial Outcomes & Findings for A Study to Learn About PAXLOVID (a Commercial Medicine) In People With COVID-19 (NCT NCT05263908)
NCT ID: NCT05263908
Last Updated: 2025-09-03
Results Overview
Adverse drug reaction (ADR) was a treatment-related adverse event and any untoward medical occurrence attributed to Paxlovid PACK in a participant who received Paxlovid PACK. Serious adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Paxlovid PACK was assessed by the physician.
Recruitment status
COMPLETED
Target enrollment
3346 participants
Primary outcome timeframe
From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45 days.
Results posted on
2025-09-03
Participant Flow
Participant milestones
| Measure |
Paxlovid PACK (Nirmatrelvir/Ritonavir)
Participants who received Paxlovid PACK as indicated in the approved local product document for the first time were observed from the start date of treatment with Paxlovid PACK to 28 days after the end of treatment (the day following the end of treatment was defined as Day 1). The dosage can be adjusted as per physician's discretion.
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|---|---|
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Overall Study
STARTED
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3346
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Overall Study
COMPLETED
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2948
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Overall Study
NOT COMPLETED
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398
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Reasons for withdrawal
| Measure |
Paxlovid PACK (Nirmatrelvir/Ritonavir)
Participants who received Paxlovid PACK as indicated in the approved local product document for the first time were observed from the start date of treatment with Paxlovid PACK to 28 days after the end of treatment (the day following the end of treatment was defined as Day 1). The dosage can be adjusted as per physician's discretion.
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|---|---|
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Overall Study
No informed consent for publication of study results
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397
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Overall Study
CRF not collected
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1
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Paxlovid PACK (Nirmatrelvir/Ritonavir)
n=2829 Participants
Participants who received Paxlovid PACK as indicated in the approved local product document for the first time were observed from the start date of treatment with Paxlovid PACK to 28 days after the end of treatment (the day following the end of treatment was defined as Day 1). The dosage can be adjusted as per physician's discretion.
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|---|---|
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Age, Customized
<15 years
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2 Participants
n=2829 Participants
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Age, Customized
≥15 and <65 years
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1404 Participants
n=2829 Participants
|
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Age, Customized
≥65 years
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1423 Participants
n=2829 Participants
|
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Sex: Female, Male
Female
|
1324 Participants
n=2829 Participants
|
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Sex: Female, Male
Male
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1505 Participants
n=2829 Participants
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PRIMARY outcome
Timeframe: From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45 days.Population: The safety analysis set (2829 participants) comprised of participants who satisfied the inclusion criteria. Participants with no informed consent for publication of study results, no information on administration, and no information on adverse events - no re-visits were excluded.
Adverse drug reaction (ADR) was a treatment-related adverse event and any untoward medical occurrence attributed to Paxlovid PACK in a participant who received Paxlovid PACK. Serious adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Paxlovid PACK was assessed by the physician.
Outcome measures
| Measure |
Paxlovid PACK (Nirmatrelvir/Ritonavir)
n=2829 Participants
Participants who received Paxlovid PACK as indicated in the approved local product document for the first time were observed from the start date of treatment with Paxlovid PACK to 28 days after the end of treatment (the day following the end of treatment was defined as Day 1). The dosage can be adjusted as per physician's discretion.
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|---|---|
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Incidence of Adverse Drug Reactions
ADR
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423 Participants
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Incidence of Adverse Drug Reactions
SADR
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6 Participants
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SECONDARY outcome
Timeframe: From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45 days.Population: For the efficacy analysis set #1 (2828 participants), participant with disease not subject to the study (1 participant) was excluded from the safety analysis set.
Whether the severity of infection caused by SARS-CoV-2 had worsened was evaluated. However, when the severity was severe at the start of Paxlovid PACK and did not worsen during the observation period, it was considered as "severe at the start of treatment."
Outcome measures
| Measure |
Paxlovid PACK (Nirmatrelvir/Ritonavir)
n=2828 Participants
Participants who received Paxlovid PACK as indicated in the approved local product document for the first time were observed from the start date of treatment with Paxlovid PACK to 28 days after the end of treatment (the day following the end of treatment was defined as Day 1). The dosage can be adjusted as per physician's discretion.
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|---|---|
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Percentage of Participants With Worsening Severity (Efficacy Analysis Set #1)
Worsened
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2.19 Percentage of participants
Interval 1.68 to 2.8
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Percentage of Participants With Worsening Severity (Efficacy Analysis Set #1)
Not worsened
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94.77 Percentage of participants
The 95% Confidence Interval was not calculated.
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Percentage of Participants With Worsening Severity (Efficacy Analysis Set #1)
Severe at the start of treatment
|
0 Percentage of participants
The 95% Confidence Interval was not calculated.
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Percentage of Participants With Worsening Severity (Efficacy Analysis Set #1)
Unknown (worsening unknown)
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3.04 Percentage of participants
The 95% Confidence Interval was not calculated.
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SECONDARY outcome
Timeframe: From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 35 days.Population: For the efficacy analysis set #2 (1965 participants), participants other than outpatient at the start of treatment (863 participants) were excluded from the efficacy analysis set #1.
Whether the severity of infection caused by SARS-CoV-2 had worsened was evaluated. However, when the severity was severe at the start of Paxlovid PACK and did not worsen during the observation period, it was considered as "severe at the start of treatment."
Outcome measures
| Measure |
Paxlovid PACK (Nirmatrelvir/Ritonavir)
n=1965 Participants
Participants who received Paxlovid PACK as indicated in the approved local product document for the first time were observed from the start date of treatment with Paxlovid PACK to 28 days after the end of treatment (the day following the end of treatment was defined as Day 1). The dosage can be adjusted as per physician's discretion.
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|---|---|
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Percentage of Participants With Worsening Severity (Efficacy Analysis Set #2)
Worsened
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1.63 Percentage of participants
Interval 1.12 to 2.29
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Percentage of Participants With Worsening Severity (Efficacy Analysis Set #2)
Not worsened
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94.66 Percentage of participants
The 95% Confidence Interval was not calculated.
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Percentage of Participants With Worsening Severity (Efficacy Analysis Set #2)
Severe at the start of treatment
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0 Percentage of participants
The 95% Confidence Interval was not calculated.
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Percentage of Participants With Worsening Severity (Efficacy Analysis Set #2)
Unknown (worsening unknown)
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3.72 Percentage of participants
The 95% Confidence Interval was not calculated.
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SECONDARY outcome
Timeframe: From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 35 days.Population: For the efficacy analysis set #3 (1905 participants), participants with no risk factors of progressing to severe illness (60 participants) were excluded from the efficacy analysis set #2.
Whether the severity of infection caused by SARS-CoV-2 had worsened was evaluated. However, when the severity was severe at the start of Paxlovid PACK and did not worsen during the observation period, it was considered as "severe at the start of treatment."
Outcome measures
| Measure |
Paxlovid PACK (Nirmatrelvir/Ritonavir)
n=1905 Participants
Participants who received Paxlovid PACK as indicated in the approved local product document for the first time were observed from the start date of treatment with Paxlovid PACK to 28 days after the end of treatment (the day following the end of treatment was defined as Day 1). The dosage can be adjusted as per physician's discretion.
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|---|---|
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Percentage of Participants With Worsening Severity (Efficacy Analysis Set #3)
Worsened
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1.68 Percentage of participants
Interval 1.15 to 2.36
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Percentage of Participants With Worsening Severity (Efficacy Analysis Set #3)
Not worsened
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94.59 Percentage of participants
The 95% Confidence Interval was not calculated.
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Percentage of Participants With Worsening Severity (Efficacy Analysis Set #3)
Severe at the start of treatment
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0 Percentage of participants
The 95% Confidence Interval was not calculated.
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Percentage of Participants With Worsening Severity (Efficacy Analysis Set #3)
Unknown (worsening unknown)
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3.73 Percentage of participants
The 95% Confidence Interval was not calculated.
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SECONDARY outcome
Timeframe: 3, 5, 7, 14, 21 and 28 days after the start of administration with Paxlovid PACK.Population: For the efficacy analysis set #3 (1905 participants), participants with no risk factors of progressing to severe illness (60 participants) were excluded from the efficacy analysis set #2.
The percent probability is the percent of the participants who had COVID-19 related hospitalization or death from any cause.
Outcome measures
| Measure |
Paxlovid PACK (Nirmatrelvir/Ritonavir)
n=1905 Participants
Participants who received Paxlovid PACK as indicated in the approved local product document for the first time were observed from the start date of treatment with Paxlovid PACK to 28 days after the end of treatment (the day following the end of treatment was defined as Day 1). The dosage can be adjusted as per physician's discretion.
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|---|---|
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Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Efficacy Analysis Set #3)
3 days from the start of administration of this drug
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3.99 Percent probability
Interval 3.2 to 4.97
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Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Efficacy Analysis Set #3)
5 days from the start of administration of this drug
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4.41 Percent probability
Interval 3.58 to 5.44
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Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Efficacy Analysis Set #3)
7 days from the start of administration of this drug
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4.47 Percent probability
Interval 3.63 to 5.5
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Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Efficacy Analysis Set #3)
14 days from the start of administration of this drug
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4.80 Percent probability
Interval 3.93 to 5.87
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Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Efficacy Analysis Set #3)
21 days from the start of administration of this drug
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4.86 Percent probability
Interval 3.98 to 5.93
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Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Efficacy Analysis Set #3)
28 days from the start of administration of this drug
|
4.92 Percent probability
Interval 4.03 to 6.0
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SECONDARY outcome
Timeframe: 3, 5, 7, 14, 21 and 28 days after the start of administration with Paxlovid PACK.Population: For the efficacy analysis set #3 (1905 participants), participants with no risk factors of progressing to severe illness (60 participants) were excluded from the efficacy analysis set #2.
The percent probability is the percent of the participants who had COVID-19 related hospitalization or death from any cause. Sensitivity analysis was conducted by changing the event definition of "hospitalization for treatment of infection caused by SARS-CoV-2" as follows: there were concomitant medications for infection caused by SARS-CoV-2 or concomitant non-drug therapies due to infection caused by SARS-CoV-2 on or after the date of administration.
Outcome measures
| Measure |
Paxlovid PACK (Nirmatrelvir/Ritonavir)
n=1905 Participants
Participants who received Paxlovid PACK as indicated in the approved local product document for the first time were observed from the start date of treatment with Paxlovid PACK to 28 days after the end of treatment (the day following the end of treatment was defined as Day 1). The dosage can be adjusted as per physician's discretion.
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|---|---|
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Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Sensitivity Analysis) (Efficacy Analysis Set #3)
3 days from the start of administration of this drug
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1.42 Percent probability
Interval 0.97 to 2.06
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Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Sensitivity Analysis) (Efficacy Analysis Set #3)
5 days from the start of administration of this drug
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1.58 Percent probability
Interval 1.11 to 2.25
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Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Sensitivity Analysis) (Efficacy Analysis Set #3)
7 days from the start of administration of this drug
|
1.58 Percent probability
Interval 1.11 to 2.25
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Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Sensitivity Analysis) (Efficacy Analysis Set #3)
14 days from the start of administration of this drug
|
1.75 Percent probability
Interval 1.24 to 2.45
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Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Sensitivity Analysis) (Efficacy Analysis Set #3)
21 days from the start of administration of this drug
|
1.75 Percent probability
Interval 1.24 to 2.45
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Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Sensitivity Analysis) (Efficacy Analysis Set #3)
28 days from the start of administration of this drug
|
1.80 Percent probability
Interval 1.29 to 2.52
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Adverse Events
Paxlovid PACK (Nirmatrelvir/Ritonavir)
Serious events: 51 serious events
Other events: 474 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Paxlovid PACK (Nirmatrelvir/Ritonavir)
n=2829 participants at risk
Participants who received Paxlovid PACK as indicated in the approved local product document for the first time were observed from the start date of treatment with Paxlovid PACK to 28 days after the end of treatment (the day following the end of treatment was defined as Day 1). The dosage can be adjusted as per physician's discretion.
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|---|---|
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
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0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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Respiratory, thoracic and mediastinal disorders
Emphysema
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0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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Respiratory, thoracic and mediastinal disorders
Hypoxia
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0.07%
2/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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|
Nervous system disorders
Cerebral venous thrombosis
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0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.07%
2/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Cardiac failure
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Cardiac failure acute
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.07%
2/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
General disorders
General physical health deterioration
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
General disorders
Pyrexia
|
0.07%
2/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Appendicitis
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Bacteraemia
|
0.07%
2/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Cellulitis
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Klebsiella infection
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Pneumonia
|
0.07%
2/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Pneumonia aspiration
|
0.35%
10/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Pneumonia bacterial
|
0.11%
3/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.07%
2/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Metabolism and nutrition disorders
Marasmus
|
0.07%
2/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Musculoskeletal and connective tissue disorders
Immobilisation syndrome
|
0.07%
2/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.04%
1/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.07%
2/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.07%
2/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
Other adverse events
| Measure |
Paxlovid PACK (Nirmatrelvir/Ritonavir)
n=2829 participants at risk
Participants who received Paxlovid PACK as indicated in the approved local product document for the first time were observed from the start date of treatment with Paxlovid PACK to 28 days after the end of treatment (the day following the end of treatment was defined as Day 1). The dosage can be adjusted as per physician's discretion.
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.11%
3/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.18%
5/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.21%
6/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.46%
13/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
92/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Faeces soft
|
0.18%
5/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.11%
3/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Nausea
|
1.2%
35/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.21%
6/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.14%
4/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.60%
17/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
General disorders
Malaise
|
0.42%
12/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
General disorders
Oedema
|
0.11%
3/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
General disorders
Pyrexia
|
0.28%
8/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.18%
5/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Bronchitis
|
0.11%
3/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Oral herpes
|
0.11%
3/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Pneumonia aspiration
|
0.14%
4/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Pneumonia bacterial
|
0.11%
3/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.18%
5/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Investigations
Blood pressure decreased
|
0.18%
5/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Investigations
Fibrin D dimer increased
|
0.11%
3/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Investigations
Liver function test increased
|
0.14%
4/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.64%
18/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.14%
4/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.18%
5/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Dizziness
|
0.21%
6/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Dysgeusia
|
6.7%
189/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Headache
|
0.21%
6/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Olfactory dysfunction
|
0.11%
3/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Somnolence
|
0.14%
4/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Taste disorder
|
1.7%
48/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Psychiatric disorders
Delirium
|
0.14%
4/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Psychiatric disorders
Insomnia
|
0.21%
6/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.14%
4/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.18%
5/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.18%
5/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.11%
3/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.11%
3/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.11%
3/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.14%
4/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.49%
14/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.11%
3/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.21%
6/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Vascular disorders
Hypertension
|
0.14%
4/2829 • From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
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