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Vaccines

Clinical Narratives Request - Cervarix, August 29, 2007

To: Mr. Matthew Whitman
File: STN 125259/0 CERVARIX
RE: Clinical Narratives Request
Date: August 29, 2007
Please provide clinical narratives for the following subjects identified in the safety datasets for Protocols 008, 013, 001, 015, and 012. If any of these narratives are already included within BLA 125259, please indicate their location within the BLA.
Study 008:
PID 15532 (FI) - epilepsy/convulsion
PID 15218 (FI) - epilepsy/convulsion
PID 11323 (UK) - epilepsy/convulsion
PID 15465 (FI) - epilepsy/convulsion
PID 12480 (FI) - epilepsy/convulsion
PID 4952 (CA) - clumsiness
PID 85968 (FI) - epilepsy
PID 15928 (FI) - epilepsy
PID 11095 (UK) - epilepsy
PID 85587 (FI) - faint with seizure
PID 15553 (FI) - mononeuropathy peroneal nerve
PID 11280 (UK) - tremor (outcome not resolved)
PID 86051 (PH) - stroke, mild
Study 013:
PID 2828 (GER) - hypotonia
PID 1098 (HON) - convulsion
PID 2827 (GER) - spinal hematoma
PID 698 (COL) - seizure (M7-12)
PID 2713 (GER) - epilepsy (M7-12)
PID 1369 (HON) - epilepsy (M7-12)
Study 001:
PID 8091 (CA) - smell and taste distortion
Study 015:
PID 7769 (CA) - bilateral hand paraesthesia, severe
PID 4593 (UK) - joint stiffness and pains, not recovered
PID 4101 (RUS) - acute arthritis knee and ankle (Unknown outcome)
PID 2371 (TH) - reactive arthritis both knees, severe
PID 2670 (MX) - rheumatoid arthritis
PID 17284 (AUS) - psoriatic arthritis
PID 21836 (TW) - neck Mass
PID 2982 (NL) - neuralgia fingers, not recovered, causal
PID 1520 (PH) - hypokinesia, recovering, causal
Study 012:
PID 3006 (RUS) - neuropathy, not specified, recovering
PID 1063 (ESTONIA) - arthritis (Not Serious or AID)
Study 014:
PID 187 (GER) - mild CVA, recovered with sequelae
PID 714 (GER) - tremor, recovering
Study 016:
PID 4510 (Center 23469) - hypotonia, recovering